Director – Sustaining Engineering
Posted on 4/3/2024
Element Science

51-200 employees

Develops wearable medical devices for heart disease treatment
Company Overview
Element Science, Inc. is a patient-centric medical device company that combines user-focused design with rigorous medical device development and data science application, focusing on addressing heart disease, a leading cause of death. Their first product, funded by Google Ventures and Third Rock Ventures, is designed to redefine treatment for sudden cardiac death, a disease that claims over 300,000 lives in the US annually. The company's team, with diverse experiences from successful start-ups and top medical device companies, is dedicated to improving patient lives and shaping the future of medical technology.
Data & Analytics
Hardware

Company Stage

Series C

Total Funding

$183.1M

Founded

2013

Headquarters

San Francisco, California

Growth & Insights
Headcount

6 month growth

3%

1 year growth

18%

2 year growth

72%
Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Quality Assurance (QA)
CategoriesNew
QA & Testing
Quality Assurance
Requirements
  • Bachelor's in a mechanical, electrical, biomedical or equivalent engineering discipline (advanced degree preferred)
  • Minimum 10+ years of engineering related experience and/or training, preferably with Class II or Class III medical devices. Minimum 7+ years of management experience.
  • Thorough understanding of FDA Medical Device GMP, ISO 13485, ISO 14971 and European MDD requirements. Demonstrated ability to optimize product design for purpose and manufacture and continuously improve production processes within a lean resource start-up environment.
Responsibilities
  • Develop and implement strategic plans for sustaining engineering activities, aligning with company’s objectives and regulatory requirements.
  • Recruit, hire, train, guide and deliver career development for sustaining engineering staff.
  • Primary lead contact for other functions such as PMO, Sales, Finance, QA, R&D, Manufacturing to drive product improvements and resolve technical issues. Collaborate and communicate effectively with stakeholders to ensure alignment and transparency to achieve company objectives.
  • Oversee all aspects of commercial product lifecycle, including design changes, product enhancements, and component obsolescence management. Ensure that products meet or exceed quality, performance, and regulatory standards throughout their lifecycle.
  • Identify and mitigate risks associated with product changes, quality issues, and regulatory compliance. Implement risk management processes and tools to assess and mitigate risks throughout the product lifecycle.
  • Drive initiatives to improve manufacturing efficiency, reduce scrap and rework, and optimize supply chain processes. Continuously monitor production costs/yields and standards to ensure that products are manufactured at the lowest costs while maintaining product quality and compliance.
  • Develop and implement Sustaining Engineering annual operating and capital budgets to meet long-term company and department objectives.
  • Lead assessments on the selection of suitable capital equipment and systems for optimal balanced line performance. Make final recommendations to management.
  • Promote a culture of continuous improvement within the sustaining engineering team and across the organization. Implement best practices, tools, and methodologies to enhance productivity, quality, and innovation.
  • Support the company’s Quality Policy and Quality System and participate in maintenance, continuous improvement, and periodic review of the Quality System, including plans and metrics, and their integration into the strategic and annual business plans.
  • Ensure that manufacturing is in compliance with FDA, GMP, ISO 13485, ISO 14971 and MDD requirements.
  • Perform other duties as assigned.